| Abstrakt: |
The FDA Approval Process for Medical Devices Training Course is designed for regulatory, technical, clinical, and quality professionals seeking an understanding of the FDA medical device approval process. The seminar covers key principles, legal and regulatory requirements, device classification, and the approval processes for various applications like 510(k), IDE, PMA, HDE, and De Novo. The course includes case studies, up-to-date information on legislation, and guidance documents, and is led by an experienced trainer with expertise in medical devices and in vitro diagnostics. Participants will gain insights into FDA processes, premarket submissions, and areas of change in the medical device regulatory landscape. [Extracted from the article] |
